Barriers to Fair Access Assessment - Final Protocol May 12, 2021 Institute for Clinical and Economic Review - ICER
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Barriers to Fair Access Assessment
Final Protocol
May 12, 2021
Institute for Clinical and Economic Review
©Institute for Clinical and Economic Review, 2021Table of Contents
1. Executive Summary ............................................................................................................................ 1
2. Background ........................................................................................................................................ 3
2.1 Background ................................................................................................................................ 3
2.2 Objectives .................................................................................................................................. 3
2.3 Research Questions.................................................................................................................... 3
2.4 Timeline ..................................................................................................................................... 4
3. Role of the Working Group ................................................................................................................ 5
4. List of Included “Cost-effective” Drugs .............................................................................................. 6
4.1 Initial list of drugs....................................................................................................................... 6
4.2 Updating drug prices .................................................................................................................. 6
4.3 Final list ..................................................................................................................................... 7
5. List of Payers and Identification of Relevant Coverage Policies ........................................................ 9
6. Determination of Concordance of Coverage Policies with Fair Access Criteria .............................. 10
Table 6.3 Step Therapy Fair Design Criteria .................................................................................... 12
Figure 6.1 Cost-Sharing Fairness Criteria Algorithm ........................................................................ 14
6.1 Process for comparing coverage policies to fair access criteria ................................................. 14
7. Analytic Plan ..................................................................................................................................... 15
8. Payer and Patient Review Prior to Public Release ........................................................................... 17
9. Changes in Process ........................................................................................................................... 18
©Institute for Clinical and Economic Review, 20211. Executive Summary The national debate about drug pricing has focused great attention on methods to determine whether the price of a drug is “fair” or “reasonable.” A question far less examined is how to determine whether insurance coverage is providing fair access to that drug. It appears widely agreed that cost sharing and drug coverage criteria serve everyone’s interest when they steer patients toward evidence-based use of treatments that achieve equal or better outcomes at lower costs. But this level of conceptual agreement does little to help advance thinking on how to assess and judge specific cost-sharing provisions and prior authorization protocols. Is it fair to have patients pay at the highest cost-sharing level when there is only a single drug available in a drug class? What are the circumstances in which step therapy is a reasonable approach to limiting coverage? When is it appropriate for the clinical criteria required for coverage to be narrower than the Food and Drug Administration (FDA) labeled indication? And for all of these questions, how should the pricing of a drug factor in to whether certain strategies to limit or steer patient access are appropriate? To answer these questions, ICER has developed a set of appropriateness criteria for cost-sharing and for prior authorization protocols for pharmaceutical coverage as described in its white paper Cornerstones of “Fair” Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals published on September 28, 2020. These appropriateness criteria are based on analysis of prior policy and ethical research, with active deliberation and revision following a December 2019 ICER Policy Summit with representatives from patient groups, clinical specialty societies, private payers, and the life science industry. An important next step is to put these criteria into action. ICER’s Barriers to Fair Access Assessment will take the fair access criteria set and apply them to evaluate the coverage policies of 28 drugs across the largest formularies (by covered lives) of the 15 largest commercial payers in the US. Work on this project will begin during the summer of 2020 and the first report of the Barriers to Fair Access Assessment is scheduled for release in fall 2021. The initial focus of this evaluation will be on coverage policies for drugs that have been shown in ICER reports to have average net prices among commercial US payers that fall within a reasonable cost-effectiveness range. ICER’s goal in developing the fair access criteria was to provide a tool for all health care participants; in our initial Barriers to Fair Access Assessment we will apply the criteria set ourselves to evaluate the extent to which we believe current coverage policies meet key standards for appropriate design and implementation. ICER will perform analyses of the proportion of criteria that are met across drugs, conditions, and payers. We will leverage the MMIT Analytics Market Access Database for formulary data. ©Institute for Clinical and Economic Review, 2021 Page 1
To help provide important guidance on this assessment, the Barriers to Fair Access Assessment will benefit from ongoing input from a multi-stakeholder Working Group consisting of representatives from leading patient advocacy groups, clinical societies, private payers, pharmacy benefit managers, and life sciences companies. The Working Group will advise ICER on the application of the fair access criteria to coverage policies; provide insight into the patient experience with prescription drug coverage and access; and advise on important nuances in the interpretation of payer coverage policies. ©Institute for Clinical and Economic Review, 2021 Page 2
2. Background 2.1 Background ICER has developed a set of design and implementation criteria for drug prior authorization protocols in the September 28, 2020 white paper, Cornerstones of “Fair” Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals. These criteria are intended to represent requirements that must be met in order for the prior authorization protocol to be appropriate, or, in other words, to ensure fair access. The criteria are based on analysis of prior policy and ethical research, and have undergone active deliberation and revision following a December 2019 ICER Policy Summit with representatives from patient groups, clinical specialty societies, private payers, and the life science industry. 2.2 Objectives The ICER Barriers to Fair Access Assessment will apply the fair access criteria set to evaluate the coverage policies of 15 of the largest private payers in the US. In this first iteration of the assessment, we will focus the evaluation on coverage policies for 28 drugs that have been the subject of ICER evidence reviews and have been determined to be priced within a reasonable cost- effectiveness range. The short-term goal of this assessment is to produce a report that evaluates the extent to which the prior authorization protocols for these fairly-priced drugs meet the fair access criteria. We envision this report as being repeated annually, with additional drugs and payers added to the evaluation. The overall objective of the assessment is to test whether the fair access criteria can help bring greater transparency to the public debates about fair insurance coverage for drugs and, in addition, promote the positive linkage of fair pricing with fair access that will advance the best interests of patients and the health system. 2.3 Research Questions The overarching research question this project will address is whether the prior authorization policies for drugs priced within reasonable cost-effectiveness ranges meet the criteria for fair access. Within this broad research question, we will perform analyses to assess the rate of concordance of prior authorization policies with the fair access criteria. Separate analyses will be done to analyze rates of concordance by: Individual fair access criterion Drug Condition Across payers in scope Individual payers ©Institute for Clinical and Economic Review, 2021 Page 3
2.4 Timeline The final report for this project will be released in fall 2021. The timeline leading up to the posting of the final report includes recruitment of a Working Group, notification to payers who will be included in the analysis, conducting the analysis, sharing a draft report with payers and allowing them time to provide the team with comments. A full timeline including milestone dates will be posted on ICER’s website. ©Institute for Clinical and Economic Review, 2021 Page 4
3. Role of the Working Group
To help provide important guidance on this project, the Barriers to Fair Access Assessment benefits
from ongoing input from a multi-stakeholder Working Group consisting of representatives from
leading patient advocacy groups, clinical societies, private payers, pharmacy benefit managers, and
life sciences companies. The Working Group advises ICER on the application of the fair access
criteria to coverage policies; provides insight into the patient experience with prescription drug
coverage and access, including real-world examples; and advises on important nuances in the
interpretation of payer coverage policies. The Working Group members are:
• Cat Davis Ahmed, MBA, Vice President of Policy and Outreach, Familial
Hypercholesterolemia Foundation
• Alan Balch, PhD, Chief Executive Officer, Patient Advocate Foundation
• Robert W. Dubois, MD, PhD, Interim President and Chief Executive Officer, Chief Science
Officer, National Pharmaceutical Council
• Patrick Gleason, PharmD, Assistant Vice President of Health Outcomes, Prime Therapeutics
• Barbara Henry, Manager, Clinical Pharmacy Services, Harvard Pilgrim Health Care
• Leah Howard, JD, Chief Operating Officer, National Psoriasis Foundation
• Cliff Hudis, MD, FACP, FASCO, Chief Executive Officer. American Society of Clinical Oncology
• Anna Hyde, Vice President of Advocacy and Access, Arthritis Foundation
• Rebecca Kirch, JD, Executive Vice President, National Patient Advocate Foundation
• Eleanor Perfetto, PhD, MS, Executive Vice President, National Health Council
• Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute
• Saira Sultan, President, Connect4Strategies (representing The Haystack Project)
• Bari Talente, Executive Vice President, Advocacy, National Multiple Sclerosis Society
• Douglas White, MD, PhD, Treasurer, American College of Rheumatology
©Institute for Clinical and Economic Review, 2021 Page 54. List of Included “Cost-effective” Drugs As described in greater detail below, the process for the analysis will start by identifying drugs within ICER reviews that are currently priced in accordance with reasonable cost-effectiveness thresholds. These drugs will be termed the list of “cost-effective” drugs. 4.1 Initial list of drugs Drugs eligible for consideration are those subject to a cost-effectiveness analysis in an ICER report from 2015 to 2020 and which were determined at the time of their original report to have an incremental cost-effectiveness ratio based on the WAC or net price at or below the price needed to reach $150,000 per equal value of life years gained (evLYG) or quality-adjusted life year (QALY), whichever price was higher. For these drugs we will update the ceiling price needed to meet the cost-effectiveness threshold to 2020 prices using the medical care component of the Consumer Price Index. 4.2 Updating drug prices To determine whether drugs are currently priced at or below this cost-effectiveness threshold we will update estimated net prices by using data from SSR Health, LLC, the health care division of SSR, LLC, an independent investment research firm. To derive a net price, SSR Health combines data on unit sales with publicly disclosed US sales figures. Discounts, rebates, concessions to wholesalers and distributors, and patient assistance programs are subtracted from gross sales to derive a net price. To estimate the most recent average net price in the US market, we will average net price data across the four most recently available quarters for which SSR data is available (October 2019- September 2020), to account for seasonal or other sources of annual price fluctuations. To confirm the validity of the SSR net prices, we will compare them to the Wholesale Acquisition Cost (WAC) and the Federal Supply Schedule Service (FSS). In cases where we deem the SSR net prices to be unreliable (such as the net prices being higher than the WAC), or where SSR prices are not available, we will use price estimates from FSS. If no data is available in either SSR or FSS, we will use list prices reported in Redbook. For physician administered drugs we will be using the same price data that was used in the report, which consists of the WAC price plus a markup. SSR reports net prices on a per unit basis. We will convert the unit prices as listed in SSR to annual prices using the dosing assumptions used in the economic evaluation of our reports. For drugs with loading doses or dose-escalation regimens, we will use the maintenance dose to calculate annual costs (i.e., second year costs) for consistency. Drugs that require weight-based dosing will use the same weight assumptions as described in the economic evaluation section of our reports. The ©Institute for Clinical and Economic Review, 2021 Page 6
remainder of partially used vials will be counted as medical waste. Pricing calculations and
assumptions will be independently validated by another member of the research team and
discrepancies will be resolved via a consensus process.
4.3 Final list
A final list of cost-effective drugs was generated using the methodology described above.
Information on the cost-effective drugs will be abstracted according to the table shell below.
Table 4.1 Cost-Effective Drug List Table Shell
Ceiling Price
Drug Name to Meet Current Access and
Drug Name Route of
Brand Indication Cost- Price Affordability
Generic Administration
effectiveness Estimate Alert?
Threshold
Alemtuzumab Lemtrada Multiple Sclerosis IV
Dupilumab Dupixent Atopic dermatitis SC
Erenumab Aimovig Chronic Migraine SC
Fremanezumab Ajovy Chronic Migraine SC
Elagolix Orilissa Endometriosis oral
Onasemnogene Zolgensma Spinal muscular IV
Abeparvovec atrophy
Tisagenlecleucel Kymriah Acute IV
lymphoblastic
leukemia
Infliximab Remicade Rheumatoid IV
Arthritis
Infliximab Remicade Psoriasis IV
Guselkumab Tremfya Psoriasis SC
Apremilast Otezla Psoriasis oral
Brodalumab Siliq Psoriasis SC
Secukinumab Cosentyx Psoriasis SC
Ixekizumab Taltz Psoriasis SC
Ustekinumab Stelara Psoriasis SC
Afatinib Gilotrif EGFR Mutation- oral
positive Metastatic
Non-Small Cell
Lung Cancer
Emicizumab Hemlibra Hemophilia A SC
Alirocumab Praluent Heterozygous SC
familial
©Institute for Clinical and Economic Review, 2021 Page 7hypercholesterole
mia or CACVD
Sacubitril/ Entresto Congestive heart oral
Valsartan failure
Olaparib Lynparza Ovarian Cancer – oral
Recurrent BRCA-
Mutated
Axicabtagene Yescarta Adult aggressive B- IV
ciloleucel Cell
Plasma-derived Haegarda Hereditary SC
C1-INH Angioedema
Gefitinib Iressa Lung cancer – non oral
small-cell (tkis)
Insulin Degludec Tresiba Diabetes SC
Ubrogepant Ubrelvy Acute Migraine oral
Rimegepant Nurtec Acute Migraine oral
Icosapent Ethyl Vascepa Cardiovascular oral
Disease
Rivaroxoban Xarelto Cardiovascular oral
Disease
©Institute for Clinical and Economic Review, 2021 Page 85. List of Payers and Identification of Relevant
Coverage Policies
We will review and abstract data from the largest formularies and coverage policies among 15 of
the largest commercial payers (by covered lives) in the US as identified in the MMIT Analytics
Market Access Database. Optum, one of the largest PBMs, is not included in the analysis because
the details of its prior authorization policies were not available. The entity (payer or PBM) that
controls the coverage decision is assigned the covered life. Medicare Private Drug Plans and
Managed Care Plans and individual state Medicaid policies will not be evaluated in this review. The
final list of payer formularies is listed in Table 5.1.
Table 5.1. Payer Formularies in Scope
Payer/PBM Formulary
CVS Health (Aetna) CVS Caremark Performance Standard Control w/ Advanced
Specialty Control
Express Scripts PBM Express Scripts National Preferred with Advantage Plus
UnitedHealth Group, Inc. UnitedHealthCare Advantage Three Tier
CIGNA Health Plans, Inc. Cigna Standard Three Tier
Kaiser Foundation Health Plans, Inc. Kaiser Permanente Southern California
Anthem, Inc. Anthem National Three Tier
MC-RX MC-RX Formulary
Blue Cross Blue Shield of Massachusetts BCBS Massachusetts Three Tier
Elixir PBM Elixir Standard Formulary
Blue Shield of California Blue Shield of California Plus Formulary
Health Care Service Corporation BCBS of Illinois Basic 6 Tier
Florida Blue Florida Blue Three Tier
Highmark, Inc. Highmark Blue Cross Blue Shield 3 Tier
MedImpact Healthcare Systems, Inc. MedImpact Portfolio High Formulary
Blue Cross Blue Shield of Minnesota BCBS of Minnesota FlexRx Three Tier
©Institute for Clinical and Economic Review, 2021 Page 96. Determination of Concordance of Coverage
Policies with Fair Access Criteria
As mentioned earlier, the available coverage policies on cost-effective drugs will be evaluated to
determine whether they meet a set of fair access criteria. Of course, there are many things that
have to happen appropriately for patients to receive “fair access,” and not all of these factors,
including documentation burdens, and payer responsiveness to patients and clinicians, can be
evaluated simply by reading written coverage policies. This project will therefore focus on several
narrow elements that can be judged through available policies: cost sharing, clinical eligibility,
restrictions on prescriber qualifications, and step therapy. For the cost-sharing criteria, “class” will
be defined as drugs with the same mechanism of action or that are established as clinically
equivalent options in clinical guidelines. The fair design criteria for these elements are describe in
further detail below. All criteria are listed below, however not all will be evaluable at this stage of
the project.
Table 6.1 Cost Sharing Fair Design Criteria
Cost Sharing
In scope for
Fair Access Criteria
this review?
Patient cost sharing should be based on the net price to the plan sponsor, not the No
unnegotiated list price.
All medications identified by the IRS as high-value therapies should receive pre- No
deductible coverage within high deductible health plans.
At least one drug in every class should be covered at the lowest relevant cost-sharing Yes
level unless all drugs are priced higher than an established fair value threshold
If all drugs in a class are priced so that there is not a single drug that represents a fair Yes
value as determined through value assessment, it is reasonable for payers to have all
drugs on a higher cost-sharing level.
If all drugs in a class are priced so that they represent a fair value, it remains reasonable Yes
for payers to use preferential formulary placement with tiered cost sharing to help
achieve lower overall costs.
As part of economic step therapy, when patients try a lower cost option with a lower No
cost sharing level but do not achieve an adequate clinical response, cost sharing for
further therapies should also be at the lower cost sharing level as long as those further
therapies are priced fairly according to transparent criteria
See also Figure 6.1 for a visual representation of the cost sharing criteria algorithm.
©Institute for Clinical and Economic Review, 2021 Page 10Table 6.2 Clinical Eligibility Fair Design Criteria
Clinical Eligibility
In scope for
Fair Design Criteria
this review?
Payers should offer alternatives to prior authorization protocols such as programs that No
give feedback on prescribing patterns to clinicians or exempt them from prior
authorization requirements (“gold carding”) if they demonstrate high fidelity to
evidence-based prescribing.
Payers should document at least once annually that clinical eligibility criteria are based Yes
on high quality, up-to date evidence, with input from clinicians with experience in the
same or similar clinical specialty.
Clinical eligibility criteria should be developed with explicit mechanisms that require Yes
payer staff to document that they have:
• Considered limitations of evidence due to systemic under-representation of minority
populations; and
• Sought input from clinical experts on whether there are distinctive benefits and harms
of treatment that may arise for biological, cultural, or social reasons across different
communities; and
• Confirmed that clinical eligibility criteria have not gone beyond reasonable use of
clinical trial inclusion/exclusion criteria to interpret or narrow the FDA label language in
a way that disadvantages patients with underlying disabilities unrelated to the
condition being treated.
For all drugs: Clinical eligibility criteria that complement the FDA label language may be Yes
used to:
• Set standards for diagnosis; and/or
• Define indeterminate clinical terms in the FDA label (e.g., “moderate-to-severe”) with
explicit reference to clinical guidelines or other standards; and/or
• Triage patients by clinical acuity when the payer explicitly documents that triage is
both reasonable and necessary because:
o The size of the population included within the FDA label is extremely large, and
there is a reasonable likelihood that many patients would seek treatment in the
short term; AND
o The clinical infrastructure is not adequate to treat all patients seeking care
and/or broad coverage would create such substantial increases in short-term
insurance premiums or other financial strain that patients would be harmed
through loss of affordable insurance; AND
©Institute for Clinical and Economic Review, 2021 Page 11o Acuity can be determined on objective clinical grounds and waiting for
treatment will not cause significant irremediable harm.
For drugs with prices or price increases that have not been formally deemed No
unreasonable: Except for the three purposes outlined above, clinical eligibility criteria
should not deviate from the FDA label language in a manner than would narrow
coverage.
For drugs with prices or price increases that have not been formally deemed No
unreasonable: Documentation that patients meet clinical eligibility criteria should
represent a light administrative burden, including acceptance of clinician attestation in
lieu of more formal medical record documentation unless documentation is critical to
ensure patient safety.
For drugs with prices or price increases that have been formally deemed No
unreasonable: Clinical eligibility criteria may narrow coverage by applying specific
eligibility criteria from the pivotal trials used to generate evidence for FDA approval if
implemented with reasonable flexibility and supported by robust appeals procedures as
described in the implementation criteria.
For drugs with prices or price increases that have been formally deemed No
unreasonable: Documentation requirements to demonstrate that patients meet clinical
eligibility criteria may represent a modest administrative burden, including
requirements for medical record confirmation of key criteria instead of simple clinician
attestation. In all cases, however, administrative burden should not result in major
barriers to care for patients who meet criteria, and payers should perform and post
publicly annual evaluations for each drug of rates of ultimate coverage approval
following initial coverage denial due to documentation failures.
Table 6.3 Step Therapy Fair Design Criteria
Step Therapy and Required Switching
In scope for
Fair Access Criteria
this review?
In order to justify economic step therapy policies as appropriate, payers should No
explicitly affirm or present evidence to document all of the following:
• Use of the first-step therapy reduces overall health care spending, not just drug
spending
• The first-step therapy is clinically appropriate for all or nearly all patients and does not Yes
pose a greater risk of any significant side effect or harm.
• Patients will have a reasonable chance to meet their clinical goals with first-step
therapy.
©Institute for Clinical and Economic Review, 2021 Page 12• Failure of the first-step drug and the resulting delay in beginning the second-step
agent will not lead to long-term harm for patients.
• Patients are not required to retry a first-line drug with which they have previously had
adverse side effects or an inadequate response at a reasonable dose and duration.
In order to justify required switching policies as appropriate, payers should explicitly No
affirm or present evidence to document all of the following:
• Use of the required drug reduces overall health care spending.
• The required switch therapy is based on the same mechanism of action or presents a Yes
comparable risk and side effect profile to the index therapy.
• The required switch therapy has the same route of administration or the difference in
route of administration will create no significant negative impact on patients due to
clinical or socio-economic factors.
• Patients are not required to switch to a drug that they have used before at a
reasonable dose and duration with inadequate response and/or significant side effects,
including earlier use under a different payer.
Table 6.4 Provider Qualifications Fair Design Criteria
Provider Qualifications
In scope for
Fair Access Criteria
this review?
Restrictions of coverage to specialty prescribers are reasonable when payers explicitly Yes
affirm one or more of the following justifications:
• Accurate diagnosis and prescription require specialist training, with the risk that non-
specialist clinicians would prescribe the medication for patients who may suffer harm or
be unlikely to benefit.
• Determination of the risks and benefits of treatment for individual patients requires
specialist training due to potential for serious side effects of therapy.
• Dosing, monitoring for side effects, and overall care coordination require specialist
training to ensure safe and effective use of the medication.
Requiring that non-specialist clinicians attest they are caring for the patient in Yes
consultation with a relevant specialist is a reasonable option when the condition is
frequently treated in primary care settings but some elements of dosing, monitoring for
side effects, and/or overall coordination of care would benefit from specialist input for
many patients.
©Institute for Clinical and Economic Review, 2021 Page 13Figure 6.1 Cost-Sharing Fairness Criteria Algorithm
Is the fairly priced target
drug in the lowest relevant
tier for that class?
Yes No
Is at least 1 drug in the
class covered at the lowest
Meets cost sharing criteria
tier relevant to that class?
Yes No
Meets cost sharing criteria Does not meet cost sharing
criteria
6.1 Process for comparing coverage policies to fair access criteria
For each drug, ICER research staff will summarize results of the policy abstraction data in Table 2
into a policy brief, which will also include details of the FDA label (including clinical trial eligibility
criteria), clinical guidelines, and policy recommendations from ICER reports to provide relevant
context. Research staff will make preliminary judgments regarding whether the coverage policy
does or does not meet each fair design criterion, and then this judgment will be reviewed by an
internist on the ICER staff. If the ICER clinician feels that clinical expert input is needed to
determine whether a coverage policy meets the fair design criterion, ICER will seek to discuss the
question with an expert involved in the original ICER report on that drug.
©Institute for Clinical and Economic Review, 2021 Page 147. Analytic Plan
Our analyses will be both quantitative and qualitative in nature.
Quantitative analyses of the concordance of coverage policies with fair design criteria will examine:
Table 7.1. Rate of Concordance by Fair Design Criterion
# of payer policies across all drugs meeting criteria/ all
Cost sharing
payer policies
# of payer policies across all drugs meeting criteria/ all
Clinical eligibility criteria
payer policies
# of payer policies across all drugs meeting criteria/all
Step Therapy
payer policies
# of payer policies across all drugs meeting criteria/all
Prescriber restrictions
payer policies
Table 7.2. Rate of Concordance by Drug
Cost Sharing Clinical Eligibility Prescriber
Step Therapy
Criteria Restrictions
# of payer policies # of payer policies # of payer policies # of payer policies
Drug 1 meeting criteria/ meeting criteria/ meeting criteria/ meeting criteria/
all payer policies all payer policies all payer policies all payer policies
# of payer policies # of payer policies # of payer policies # of payer policies
Drug 2 meeting criteria/ meeting criteria/ meeting criteria/ meeting criteria/
all payer policies all payer policies all payer policies all payer policies
Table 7.3. Rate of Concordance by all Payers
# of payers with >50% of policies across all drugs
Cost sharing
meeting criteria/# of payers
# of payers with >50% of policies across all drugs
Clinical eligibility criteria
meeting criteria/# of payers
# of payers with >50% of policies across all drugs
Step Therapy
meeting criteria/# of payers
# of payers with >50% of policies across all drugs
Prescriber restrictions
meeting criteria/# of payers
©Institute for Clinical and Economic Review, 2021 Page 15Table 7.4. Rate of Concordance by Individual Payer
Cost Sharing Clinical Eligibility Prescriber
Step Therapy
Criteria Restrictions
# of policies
Anthem # of policies across all # of policies across all # of policies across all
across all drugs
(Largest drugs meet drugs meet drugs meet criteria/all
meet criteria/all
Formulary) criteria/all policies criteria/all policies policies
policies
United # of policies
# of policies across all # of policies across all # of policies across all
Healthcare across all drugs
drugs meet drugs meet drugs meet criteria/all
(Largest meet criteria/all
criteria/all policies criteria/all policies policies
Formulary) policies
Additional quantitative analyses may be pursued to evaluate whether rates of concordance vary by
route of administration, level of competition in the drug category, estimated eligible population,
and other factors.
Qualitative information will be gathered from patient groups and clinical specialty societies to
provide context to the quantitative analyses. The methods by which this information will be
gathered is yet to be determined, but could include submission of published and unpublished data
on barriers to access, examples of barriers to access that may reflect failure to meet fair access
criteria or problems beyond those criteria evaluated directly in this report.
©Institute for Clinical and Economic Review, 2021 Page 168. Payer and Patient Review Prior to Public Release For any payer with policies judged not to meet fair access criteria ICER will provide them with the opportunity to review our judgment and provide comment if they feel the policy has been misinterpreted or misjudged. All payers will also be offered the opportunity to provide a written comment for inclusion with the material posted publicly when the report is released. Draft results of the evaluation will also be shared with patient representatives of the Working Group to get feedback on how the fair access criteria are being judged across different coverage policies. ©Institute for Clinical and Economic Review, 2021 Page 17
9. Changes in Process Despite benefiting from the input of our Working Group, we expect that we will encounter situations throughout the research process that have not been fully anticipated. Thus, it should be expected that the fair access judging process and the analysis plan may change. ICER will be monitoring the process as it progresses and may need to alter aspects of the review if needed to maintain transparency and fairness to all parties. ICER commits to flexibility within this first review and to transparency about any needed changes. ©Institute for Clinical and Economic Review, 2021 Page 18
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